The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Berichrom Antithrombin Iii (a).
| Device ID | K933125 |
| 510k Number | K933125 |
| Device Name: | BERICHROM ANTITHROMBIN III (A) |
| Classification | Antithrombin Iii, Two Stage Clotting Time Assay |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Lori Baranauskas |
| Correspondent | Lori Baranauskas BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | JPE |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-28 |
| Decision Date | 1994-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768013478 | K933125 | 000 |
| 00842768013461 | K933125 | 000 |
| 00630414639659 | K933125 | 000 |
| 00630414639444 | K933125 | 000 |